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NCT06978582Active, not recruiting

Effectiveness and Safety of a Tele-Rehabilitation Program on Fatigue and Related Variables in Chronic Fatigue Syndrome and Post COVID Syndrome

Effectiveness and Safety of a Tele-rehabilitation Program Based on Mindful and Conscious Movement-based Exercise vs Conventional Low-intensity Exercise on Fatigue and Related Variables in Patients With Chronic Fatigue Syndrome/ Myalgic Encephalitis (CFS/ME) or Post COVID Syndrome (PCS)

Source: ClinicalTrials.gov · Last updated 28 Apr 2026

Brief summary (registry, in English)

This is a randomized, single-blind clinical trial that aims to evaluate the effectiveness of a tele-rehabilitation program based on mindful and conscious movement-based exercise (including adapted yoga, breathing exercises, and body awareness) compared to conventional exercise (low-intensity strength and aerobic training) and usual medical care (control group) over twelve weeks. The study is for people diagnosed with Chronic Fatigue Syndrome/ Myalgic Encephalitis (CFS/ME) or Post-Covid Syndrome (PCS). We will also look at how the program affects the autonomic nervous system by measuring heart rate variability (HRV). All sessions will be delivered remotely via Telehealth, so participants can take part from home. Assessments will be completed online at the beginning of the study, after three months (at the end of the intervention), and again three months later.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
147 (estimated)
First submitted
14 May 2025
Start date
Oct 2025
Primary completion date
Dec 2026
Lead sponsor
University of Seville
NCT number
NCT06978582

What you commit to

  • Study type: Interventional
  • Planned participants: 147
  • From Oct 2025 to the primary completion date, Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Recent suspicion of comorbid conditions that could explain the syndrome's associated symptoms, not yet ruled out by a qualified healthcare professional.

Other

  • Inability to use basic software required for participation in the study (e.g., Microsoft Teams, completing a Google Forms questionnaire).
  • Unwillingness to make minor adjustments to daily habits.

Who the study is looking for

  • Participants must be over 18 and under 70 years of age (to minimize the presence of comorbidities).
  • Participants must meet the latest established diagnostic criteria for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) and Post-Covid Syndrome, respectively.
  • Participants must have access to a computer, tablet, or mobile device with an internet connection to attend videoconference sessions.
  • Participants must have a mobile device compatible with the applications Cardiio: Heart Rate Monitor and Welltory, which will be used to measure heart rate (HR) and heart rate variability (HRV), respectively.
  • Participants must be able to remain seated in a chair for at least 45 continuous minutes.
  • Participants must have fluent comprehension of the Spanish language.
  • Any comorbid condition that could explain the symptomatology associated with the syndrome (such as post-infectious organ damage, heart disease, neurological disorders, cancer, severe psychiatric illness, or metabolic syndrome) must have been ruled out by a physician.

Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Facultad de Enfermería, Fisioterapia y Podología. Universidad de Sevilla (Campus Macarena, Perdigones)
Coordinator of this site? Confirm its status
SevilleSpainUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.